GMPs, which rely on risk prevention, have been made mandatory in many markets. Food safety and quality for public consumption is assured by carrying out a wide range of activities. Apart from enhancing public health, successful food safety structures preserve end user assurance and grant a sound regulatory base for domestic and global trade in food, which shores up trade and industry (Hammoudi et al., 2009; Thorpe and Bennett, 2004). The guiding principle of GMP is that quality is built into a product, and not just tested. Therefore, the product not only meets the final specifications, but also meets uniform conditions consistently. In the food safety programme matrix, GMPs becomes an integral part of quality, sanitation, regulatory compliance and hazard analysis and critical control points (HACCP) (Figure 7.1).
Figure 7.1 GMPs as common matrix in food safety programme.
7.3 Key Importance of GMPs for Roots and Tubers
The risk analysis provides a base for defining the various threats to root and tuber produce safety, determining the extent of vulnerabilities and devizing appropriate counter measures. The plant management system should then be tailored to warranty whereby quality facets linked to food processing are built-in in a fitting manner. GMPs importance in processing of tropical roots and tubers is covered by the following points:
• Provides a high level assurance that tropical roots and tubers are manufactured in a way that ensures their safety, efficacy and quality;
• Provides manufacturing conditions in such a way that the produce comply with their marketing authorization;
• Quality can be built into the product.
7.4 GMP Components
The major requirement of GMP is that the manufacturing process is completely defined before initiation and all the necessary facilities are ensured. In practice, GMPs encompass adequately trained personnel, suitable materials, premises and equipment, approved and well defined procedures, proper storage and transport facilities along with the appropriate records. The various components of GMP for processing of tropical roots and tubers are presented in Table 7.1.
Table 7.1 Major components of GMP
S. no. | Components of GMP
1 | Quality Management
2 | Quality control
3 | Good manufacturing practices (GMPs) for roots and tubers
4 | Sanitation and hygiene
5 | Qualification and validation
6 | Complaints
7 | Contract production and analysis
8 | Inspection, supplier's audits and approval
9 | Personnel and training
10 | Premises
11 | Equipment
12 | Materials
13 | Documentation
14 | Holding and distribution
7.4.1 Quality Management
The management must ensure that the products are fit for their intended use. The success of this quality objective is the responsibility of the top management and requires active participation and commitment by the whole staff in different departments and at all levels within the organization (Karmacharya, 2012). The quality policy needs to be maintained in the root and tuber processing industry. The main elements of this component is proper infrastructure, systematic organization structure, well-defined procedures, processes, resources and necessary actions that ensure a good-quality product.
7.4.2 Quality Control
The controlling quality is of prime concern in this modern era and therefore quality is not only restricted to control but it has to be assured. Hence, quality assurance, which is a proactive approach, is adopted in most organizations. Quality Control (QC) of roots and tubers, on the whole deals with establishment, validation and implementation of all QC procedures, to ensure correct packaging and labelling of materials and products, and many other aspects that concern the quality of roots and tubers.
Quality assurance (QA) covers all aspects which influence and assure the quality of the product. The product quality can be ascertained by ensuring that all activities, related to the purchasing, production, storage, filling, control and distribution of tropical roots and tubers, are carried out in a systematic manner. Quality is a part of GMPs that deals with sampling, specifications, procedures, testing and documentation. This is not limited to laboratory testing but must also be built into all activities and evaluations concerned with the quality of the root and tuber produce.
The system should also cover cases of non-conformity with regulatory and existing procedures in system. The processors need to ensure that acceptable facilities, qualified personnel and adequate procedures are available for sampling, inspection and testing of raw materials, root and tuber produce, packaging materials, and environmental settings. The system must have measures in place to correct any breakdown to accomplish GMP and monitor the efficacy of those preventive measures.
Control of Starting Materials, Intermediate and Finished Products All standard tests should be followed as per the procedure for material/product. The result should be verified before the material/product is marketed or rejected. The sampling is an important criterion before carrying out any examination, therefore the following points need to be considered:
• Samples should be representative of the lots from which they are taken in accordance with the approved procedure.
• Sampling must be ensured without contamination or any undesirable effects on quality.
• The containers used for sampling must be marked accordingly and resealed.
• Sampling equipment should be cleaned and sanitized as per the approved plan.
Test Requirements Maintaining the quality is the prime responsibility and should be documented, which includes test procedures, approving specifications, validation plans and reports, approved standards, sampling plan, analytical investigations, evaluation of results and testing materials. The report should specify the acceptance or rejection of the sample. The quality control must have trained staff and facilities along with the well-maintained and calibrated equipment to carry out the designated responsibilities efficiently.
Defect Action Levels A ceiling for defect levels should be in place, as it will provide indications for faults that are natural or unavoidable, even when foods are manufactured under good manufacturing practices. The manufacturing operations are expected to be modified/altered to reduce the level of defect to the lowest possible levels.